The VASOVIEW HEMOPRO System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels of the extremities, dissection of ducts and other structures in the extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and perioheral artery bypass or the radial artery for use in coronary artery bypass grafting. Thoracoscopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall.

Device Description

The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube and VASOVIEW HEMOPRO Harvesting Tool for cutting and sealing of vessel branches. The C-Ring/distal lens washer is independently controlled by a C-Ring Slider on the handle of the device that retracts the vessel and washes the distal tip of the Endoscope. The Harvesting Tool can be extended/retracted from the main cannula by inserting it into the Tool Adapter Port, and rotated independently. The Harvesting Tool has two curved Jaws. One Jaw contains the heating elements for branch cutting and sealing; the second Jaw is longer and has a serrated inner edge. Cutting and sealing of vessel branches is achieved in two steps: (1) capture of the branch between the HEMOPRO Jaws, and (2) simultaneous coagulation and ligation of the branch with the Jaws using direct current. Both steps are achieved by mechanical application of the Activation Toggle. Positioning of the device, cutting, and sealing are performed under endoscopic visualization. This device is intended for specific use with the VASOVIEW HEMOPRO Power Supply.

AI/ML Overview

This document describes a 510(k) submission for the MAQUET VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System, seeking substantial equivalence to a predicate device (K052274). The submission focuses on device modifications to address specific Medical Device Report (MDR) issues related to self-activation/overheating. Since this is a submission for substantial equivalence based on modifications to an existing device, the "acceptance criteria" and "device performance" are primarily demonstrated through specific performance and safety testing, rather than novel clinical performance metrics against a medical condition.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the types of tests conducted and the conclusion that the device's functionality and performance characteristics are "comparable" to the predicate device. The document does not explicitly state numerical acceptance thresholds for these tests, but rather indicates that the tests successfully demonstrated comparable performance and addressed the identified issues.

Acceptance Criteria (Implied)	Reported Device Performance
Performance Testing (General functionality comparable to predicate)	The results of the in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the currently marketed VASOVIEW HemoPro Endoscopic Vessel Harvesting System. These tests addressed MDR issues identified as self-activated/remains activated and overheating.
Burst Pressure Testing	Performed during development. Implied to meet safety standards comparable to the predicate.
Thermal Spread Testing	Performed during development. Implied to meet safety standards comparable to the predicate.
Electrical Testing (60601-1)	Performed during development. Implied to meet 60601-1 standards, which address safety requirements for medical electrical equipment.
Shelf Life Testing	Performed during development. Implied to ensure the device maintains functionality and sterility over its intended shelf life.
Substantial Equivalence	The device is found substantially equivalent to the currently marketed predicate device (K052274) based on similar intended use and fundamental scientific technology, with performance and other testing establishing equivalence.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes for the "in-vitro tests" conducted. The provenance of the data is not explicitly stated beyond being "in-vitro tests." This typically implies laboratory testing using simulated conditions or excised tissue, rather than human clinical data. The document focuses on bench testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable and not provided in the document. The study is an in-vitro engineering and performance verification study, not a clinical study requiring expert ground truth for diagnostic or clinical outcome evaluation.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving human subject data and multiple reviewers to reach a consensus on diagnoses or outcomes. This document describes technical device testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. This submission is for a physical medical device (endoscopic vessel harvesting system), not an AI-powered diagnostic or assistive technology. Therefore, no MRMC study or AI-related effectiveness metrics would be part of this type of submission.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. As mentioned above, this is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For the performance and safety tests, the "ground truth" would be established by the test standards and specifications themselves. For example, for "burst pressure testing," the ground truth is the specified pressure the device must withstand without failure. For "electrical testing 60601-1," the ground truth is compliance with the detailed requirements of the ISO 60601-1 standard. There is no biological "ground truth" in the sense of pathology or outcomes data in this in-vitro testing context.

8. The Sample Size for the Training Set

This information is not applicable and not provided. Training sets are relevant for machine learning or AI algorithms. This is a traditional medical device submission.

9. How the Ground Truth for the Training Set was Established

This information is not applicable for the same reason as point 8.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 19, 2016

MAQUET Cardiovascular, LLC Mr. Mark Dinger Sr. Regulatory Affairs Specialist 45 Barbour Pond Drive Wayne, New Jersey 07470

Re: K153194

Trade/Device Name: Vasoview Hemopro Endoscopic Vessel Harvesting System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: March 30, 2016 Received: March 31, 2016

Dear Mr. Dinger:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K153194

Device Name

VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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VASOVIEW HemoPro Endoscopic Vessel Harvesting System 510(k) Summary

Prepared in accordance with 21 CFR Part 807.92

510(k) Number:	K153194
Date Prepared:	30 October 2015
Device Owner:	MAQUET Cardiovascular LLC45 Barbour Pond DriveWayne, New Jersey 07470
Contact Personnel:Title:Email:Phone:	Mr. Mark Dinger, B.S.Sr. Regulatory Affairs Specialistmark.dinger@maquet.com973-709-7691Fax: 973-909-9954
Trade Name:	VASOVIEW HemoPro Endoscopic Vessel HarvestingSystem
Device Generic Name:	Electrosurgical cutting and coagulation device andaccessories
Classification:	According to 21 CFR 878.4400 of the Federal Food, Drugand Cosmetic Act, the device classification is Class II,Product code GEI.
Predicate Device:	K052274 VASOVIEW HemoPro Endoscopic VesselHarvesting System (SE: 21 September 2005)
Device Description:	The VASOVIEW HEMOPRO Endoscopic VesselHarvesting System is designed for use in conjunction withthe 7 mm Endoscope. The Harvesting Cannula has fourlumens which house the Endoscope, C-Ring, distal lenswasher tube and VASOVIEW HEMOPRO Harvesting Toolfor cutting and sealing of vessel branches. The C-Ring/distal lens washer is independently controlled by aC-Ring Slider on the handle of the device that retracts thevessel and washes the distal tip of the Endoscope. TheHarvesting Tool can be extended/retracted from the maincannula by inserting it into the Tool Adapter Port, androtated independently. The Harvesting Tool has two curvedJaws. One Jaw contains the heating elements for branchcutting and sealing; the second Jaw is longer and has a

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	serrated inner edge. Cutting and sealing of vessel branches is achieved in two steps: (1) capture of the branch between the HEMOPRO Jaws, and (2) simultaneous coagulation and ligation of the branch with the Jaws using direct current. Both steps are achieved by mechanical application of the Activation Toggle. Positioning of the device, cutting, and sealing are performed under endoscopic visualization. This device is intended for specific use with the VASOVIEW HEMOPRO Power Supply.
Indications for Use:	The VASOVIEW HEMOPRO System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels of the extremities, dissection of ducts and other structures in the extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or the radial artery for use in coronary artery bypass grafting. Thoracoscopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall.
Technological Characteristics	The Proposed HemoPro and the predicate devices have the following similarities: the same intended use,the same operating principles,incorporates the same basic design,sterilized using the same materials and processes,has same packaging. The Proposed HemoPro and the predicate devices have the following differences: A redesign of the electrical system in the HemoPro Tool from a Logic to a Power Switch system using the following internal components: Switch UMB: 5 Amps@ 125/250 VAC

serrated inner edge. Cutting and sealing of vessel branches is achieved in two steps: (1) capture of the branch between the HEMOPRO Jaws, and (2) simultaneous coagulation and ligation of the branch with the Jaws using direct current. Both steps are achieved by mechanical application of the Activation Toggle. Positioning of the device, cutting, and sealing are performed under endoscopic visualization. This device is intended for specific use with the VASOVIEW HEMOPRO Power Supply.

Indications for Use:

The VASOVIEW HEMOPRO System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels of the extremities, dissection of ducts and other structures in the extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or the radial artery for use in coronary artery bypass grafting. Thoracoscopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall.

Technological Characteristics

The Proposed HemoPro and the predicate devices have the following similarities: the same intended use,the same operating principles,incorporates the same basic design,sterilized using the same materials and processes,has same packaging. The Proposed HemoPro and the predicate devices have the following differences: A redesign of the electrical system in the HemoPro Tool from a Logic to a Power Switch system using the following internal components: Switch UMB: 5 Amps@ 125/250 VAC

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	Toggle and Spring Toggle Return in the Toggle• Assembly.
	Molded handle halves with modified Pad prints.•
	Pigtail adapter plug: To accommodate the electrical• pigtail of the HemoPro tool, a new part required tocapture the pigtail with the handle halves.
	The differences are not considered a technologicaldifference and are substantially equivalent to the predicatedevice.
Safety andPerformance:	MAQUET Cardiovascular's development process requiredthat the following activities be completed during thedevelopment of the HemoPro:
	• Performance testing
	• Burst Pressure testing
	• Thermal Spread testing
	• Electrical Testing 60601-1
	• Shelf life testing
	The results of the in-vitro tests conducted demonstrate thatthe functionality and performance characteristics of thedevice are comparable to the currently marketedVASOVIEW HemoPro Endoscopic Vessel HarvestingSystem.
	The reason for this 510(k) is to address the MDR issuesidentified as self activated /remains activated andoverheating.
Conclusion:	Based upon the information submitted in this Traditional510(k) premarket notification, MAQUET's VASOVIEWHemoPro Endoscopic Vessel Harvesting System issubstantially equivalent to the currently marketed predicatedevice. The VASOVIEW HemoPro Endoscopic VesselHarvesting System is similar to the predicate devices in theintended use and the fundamental scientific technology ofthe device. The performance and other testing establishedthat the VASOVIEW HemoPro Endoscopic VesselHarvesting System is substantially equivalent as thepredicate device.

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.